Skin AgingPhase 4NCT00447551

Canadian Aesthetic Experience With Sculptra Therapy

A Phase 4 study testing Poly-L-Lactic Acid in people with Skin Aging, run by Bausch Health Americas, Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary objective To evaluate the degree of correction achievable with Sculptra for nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial ageing. To document the types and incidence of device-related adverse events with Sculptra. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Skin Aging
What is being tested?: Poly-L-Lactic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteCanada
Study dates: Jan 2007to Apr 2008
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Present with nasolabial folds, mid- and lower facial volume loss, jawline laxity or other signs of facial ageing to be treated with Sculptra
The subject must be willing and able to provide written informed consent that includes a release for use of their photographs in publications. Subjects who refuse the photo release will not be eligible to participate in the study.
Female subjects must be post-menopausal for at least one year or have had a hysterectomy or tubal ligation; if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device (IUD), or spermicide in combination with a barrier method of contraception);

Who cannot join

Personal history of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine);
Known history of bleeding disorders;
Active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease);
Active hepatitis within the past year;
Subjects who are pregnant or who plan to become pregnant within the study timeframe, or who are breastfeeding;
HIV positive patients;

Show all 14Show fewer

Recent history of trauma in the face (< 1 year);
Previous use of Dermalive or Dermadeep;
Previous facial surgery within the last six months;
Recent facial filler within the last six months;
Planned surgical interventions (such as rhinoplasty, facelift, congenital defect repair) or use of other fillers or lasers for the initial six months post-Sculptra therapy;
Subjects with clinically important disease as judged by the investigator within 3 months of the start of the study (e.g., history of significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue disease, etc.), including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (severe asthma, rheumatoid arthritis, organ transplant, etc.);
Subjects who have used superficial dermal resurfacing procedures in the facial area, including chemical peel, dermabrasion, or microderm treatments within six weeks of visit 1 and for the duration of the main study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Sanofi-Aventis Administrative Office
Québec

Other trials in Canada

About this study

Official title: Canadian Study of the Use of Injectable POLY-L-LACTIC Acid (Sculptra Therapy) in Aesthetic Medicine

Primary objective To evaluate the degree of correction achievable with Sculptra for nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial ageing.

To document the types and incidence of device-related adverse events with Sculptra.

Conditions: Skin Aging
Being tested: Poly-L-Lactic Acid
Keywords: Aesthetic facial volume enhancement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Poly-L-Lactic AcidDrug
Also called Sculptra
Deep dermal injection

Study groups in NCT00447551
Study group	Role	What they receive
single group	Experimental	Not described Receives: Drug: Poly-L-Lactic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the degree of correction attainable with Sculptra (injectable PLLA) for the correction of nasolabial folds, mid-and lower facial volume loss, jawline laxicity, and other signs of facial aging.
Measured: From baseline to 6-months post-Sculptra therapy

Secondary outcomes (1)

Document the types and incidence of device adverse events with Sculptra Therapy (Injectable PLLA)
Measured: From baseline to 6-months post-Sculptra therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Apr 2008

First posted14 Mar 2007 (estimated)
Study startJan 2007
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin AgingStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00447551
Sponsor's protocol ID: POLYL_L_01777
Status last verified: Nov 2019
First submitted: 13 Mar 2007
Last updated: 19 Nov 2019
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Canadian Study of the Use of Injectable POLY-L-LACTIC Acid (Sculptra Therapy) in Aesthetic Medicine
ClinicalTrials.gov ID: NCT00447551
Acronym / sponsor ID: POLYL_L_01777
Conditions: Skin Aging
Keywords: Aesthetic facial volume enhancement
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 14 Mar 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective To evaluate the degree of correction achievable with Sculptra for nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial ageing.

To document the types and incidence of device-related adverse events with Sculptra.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
single group	Experimental	Drug: Poly-L-Lactic Acid

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Present with nasolabial folds, mid- and lower facial volume loss, jawline laxity or other signs of facial ageing to be treated with Sculptra
The subject must be willing and able to provide written informed consent that includes a release for use of their photographs in publications. Subjects who refuse the photo release will not be eligible to participate in the study.
Female subjects must be post-menopausal for at least one year or have had a hysterectomy or tubal ligation; if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device (IUD), or spermicide in combination with a barrier method of contraception);

Key exclusion criteria (14 listed)

Personal history of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine);
Known history of bleeding disorders;
Active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease);
Active hepatitis within the past year;
Subjects who are pregnant or who plan to become pregnant within the study timeframe, or who are breastfeeding;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Poly-L-Lactic AcidAlso: SculptraDeep dermal injection	Drug	single group

Primary outcome

Evaluate the degree of correction attainable with Sculptra (injectable PLLA) for the correction of nasolabial folds, mid-and lower facial volume loss, jawline laxicity, and other signs of facial aging.
Time frame: From baseline to 6-months post-Sculptra therapy

1 secondary outcome

Document the types and incidence of device adverse events with Sculptra Therapy (Injectable PLLA)
Time frame: From baseline to 6-months post-Sculptra therapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.

Related trials for Skin Aging

RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Tzortzis study director

Sanofi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Poly-L-Lactic Acid in people with Skin Aging, run by Bausch Health Americas, Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the degree of correction attainable with Sculptra (injectable PLLA) for the correction of nasolabial folds, mid-and lower facial volume loss, jawline laxicity, and other signs of facial aging. (time frame: From baseline to 6-months post-Sculptra therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00447551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.